POS1236 THE IMPACT OF ANTI-SARS-COV-2 VACCINES IN A MULTICENTER COHORT STUDY OF PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
Authors: M. Gerosa, T. Schioppo, L. M. Argolini, S. Sciascia, G. A. Ramirez, G. Moroni, R. A. Sinico, F. Alberici, L. Moroni, F. Tamborini, P. Miraglia, C. Bellocchi, L. Beretta, D. Roccatello, L. Dagna, E. Bozzolo, R. Caporali
Journal: Annals of the Rheumatic Diseases (2022)

Background Vulnerable subjects, including systemic lupus erythematosus (SLE) patients have been prioritised to receive anti-SARS-CoV-2 vaccine. Questions have been raised about the effect of vaccines on immunity and their potential role as trigger for flare. Few data about the safety of these vaccines in SLE are available Objectives To investigate the safety of different anti-SARS-CoV-2 vaccines in SLE Methods Data on SLE patients who have received anti-SARS-CoV-2 vaccine (from 12/2020 to 10/2021) were collected. Patients referred to 7 SLE tertiary centres (Lupus Clinic, ASST Pini-CTO, Milan; Nephrology Unit of Ospedale Giovanni Bosco, Turin; IRCCS Humanitas Research Hospital; Renal and Rheumatology Units, San Gerardo Hospital, Monza; ASST Spedali Civili Brescia; Lupus Clinic IRCCS Ospedale S. Raffaele, Milan, Italy; IRCCS Policlinico, Milan) Results 452 SLE patients who had received anti-SARS-CoV-2 vaccines were included (91% BNT162b2 mRNA, 8% mRNA-1273, 1% ChAdOx1-S). 12 (3%) were off therapy, 71% were on low-medium dose prednisone, 83% on anti-malarials, 50% were treated with an immunosuppressant. 9 patients transiently discontinued therapy. 119 (26%) reported adverse symptoms after the first/second shot (12% and 21%) The most frequent were fever, local reaction, fatigue and arthralgias. Nineteen (4%) patients flared up after immunisation with a 7 days median time to relapse. Baseline demographics, SLE characteristics and therapy stratified by adverse events and disease flare are reported in Table 1. Anti-dsDNA positivity, moderate/high DAS before vaccine and use of Belimumab were significantly more frequent in the group of patients flared. These patients displayed a significantly higher rate of adverse events after vaccination. Flares consisted mainly musculoskeletal and constitutional manifestations (32%), involvement of renal (21%), cardio-respiratory (16%), hematological (16%) or mucocutaneous domains (10%) was less frequent Table 1. distribution of demographic and SLE characteristics according to sides effects and disease flares after vaccination Side effects (n=119) No side effects (n=333) p-value (&lt;0.05) Disease flare (n=19) No disease flare (n=430) p-value (&lt;0.05) Age, years, median (IQR) 46 (33.5-54) 48 (35.7-57) 0.18 52 (39.5-56.0) 48 (35.0-56.9) 0.849 Disease duration, months, median (IQR) 138 (76-262) 126 (73-193) 0.30 144 (122-242) 127 (73-195) 0.249 MSK, % 84.9 84.4 1.00 78.9 84.8 0.514 Mucocutaneus, % 71.4 62.8 0.094 57.9 64.5 0.624 Renal, % 42.0 52.3 0.069 52.6 49.4 0.819 NPSLE, % 13.4 9 0.215 5.3 10.4 0.708 Cardiopulmonary % 22.7 19.8 0.510 26.3 20.3 0.562 Hematological, % 32.8 33 1.00 42.1 32.6 0.455 Constitutional symptoms % 48.7 30 0.0003* 26.3 35.3 0.473 Gastrointestinal % 4.2 3.3 0.772 5.3 3.5 0.503 Ophthalmic % 0.8 3.3 0.197 0 2.8 1.00 Secondary APS % 10.9 10.5 0.864 5.3 10.9 0.708 aPL positivity % 26.2 33.6 0.137 26.3 31.9 0.802 Anti-dsDNA positivity % 30.7 27.4 0.545 55.6 27.1 0.0142* ESR, mm/h, median (IQR) 14 (7-19) 13 (7-22) 0.730 19 (10-24) 13 (7-21) 0.125 CRP, mg/dL, median (IQR) 0.5 (0.1-0.5) 0.5 (0.3-0.6) 0.312 0.42 (0.13-0.50) 0.50 (0.30-0.5) 0.464 Urinary abnormalities, % 9.2 21.9 0.0023 21.1 18.5 0.764 Moderate or high DAS before vaccine, % 16 9.3 0.060 26.3 10.4 0.0474* No therapy before vaccine, % 0 3.6 0.0419* 0 2.8 1.00 At least 1 immunosuppressant, % 63 46.8 0.0027* 73.7 50.1 0.059 Mycophenolate, % 31.9 23.1 0.066 42.1 24.7 0.106 Methotrexate, % 5.9 6.6 1.00 5.3 6.5 1.00 Belimumab, % 21.8 13.5 0.0396* 36.8 14.8 0.0184* Rituximab ever, % 11.8 13.5 0.751 5.3 13.4 0.490 Prednisone, % 74.8 70 0.347 78.9 70.9 0.607 Conclusion our reassuring data confirm that anti-SARS-CoV-2 vaccine is safe in SLE patients and should be recommended in this clinical setting, as potential benefits widely outweigh the risk of adverse events. Treatment adjustment might be considered with the aim of minimizing the risk of side effects and/or flare, while ensuring a satisfying protection against infection References [1]Tang W et al. The Use of COVID-19 Vaccines in Patients with SLE. Curr Rheumatol Rep. 2021 12;23:79. Disclosure of Interests None declared